Cipla and Stempeutics Forge Landmark Partnership to Introduce India’s First Allogeneic Stem Cell Therapy for Knee Osteoarthritis
Cipla Limited a global pharmaceutical leader with a legacy of patient-centric innovation—has officially launched Ciplostem, a groundbreaking allogeneic mesenchymal stromal cell (MSC) therapy for the treatment of Knee Osteoarthritis (Knee OA). Developed by Stempeutics Research, a pioneer in regenerative therapeutics, Ciplostem has received regulatory approval from the Drug Controller General of India (DCGI), marking a pivotal moment in India’s biopharmaceutical landscape and Cipla’s strategic foray into orthobiologic medicine.
A New Era in Managing Chronic Joint Disease
Knee Osteoarthritis is far more than a “wear-and-tear” condition—it is a complex, chronic degenerative disease that progressively erodes joint cartilage, causes debilitating pain, and severely compromises mobility and quality of life. According to recent epidemiological data, over 48.4 million Indians were living with osteoarthritis as of 2021, with knee OA accounting for the majority of cases. Alarmingly, the disease is no longer confined to the elderly; rising rates among younger adults—driven by obesity, sedentary lifestyles, sports injuries, and metabolic disorders—underscore an urgent public health challenge.
Current standard-of-care options remain largely palliative. Patients typically rely on non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, corticosteroid injections, or viscosupplementation (hyaluronic acid injections) to manage symptoms. While these approaches offer temporary relief, they do little to halt or reverse the underlying degenerative process. In advanced cases, surgical interventions like total knee replacement become necessary—but such procedures carry significant risks, long recovery periods, and substantial costs, especially in a resource-constrained setting like India.
Against this backdrop, Ciplostem emerges as a disease-modifying therapy, designed not just to alleviate symptoms, but to actively modulate the joint’s biological environment, reduce inflammation, protect residual cartilage, and restore function.
The Science Behind Ciplostem
Ciplostem is a single-dose, intra-articular injection administered directly into the affected knee joint. Each dose contains 25 million ex vivo expanded, pooled, and cultured allogeneic mesenchymal stromal cells, derived from adult human bone marrow (BM-MSCs). These cells are co-formulated with hyaluronic acid, a naturally occurring component of synovial fluid that provides joint lubrication and structural support.
What sets Ciplostem apart is its allogeneic nature—meaning the cells are sourced from healthy donors rather than the patient themselves (autologous). This eliminates the need for invasive harvesting procedures, reduces variability, ensures batch consistency, and enables immediate off-the-shelf availability, a critical advantage in real-world clinical settings.
At the cellular level, MSCs exert their therapeutic effects through paracrine signaling—releasing a cocktail of anti-inflammatory cytokines, growth factors, and extracellular vesicles that:
- Suppress pro-inflammatory mediators (such as TNF-α and IL-1β),
- Inhibit cartilage-degrading enzymes (like matrix metalloproteinases),
- Stimulate endogenous repair mechanisms,
- Promote tissue homeostasis, and
- Modulate the local immune response within the joint.
Clinical trials, including a robust Phase 3 study conducted in India, have demonstrated that Ciplostem significantly reduces pain, improves joint function (as measured by WOMAC and VAS scores), and enhances mobility for up to 24 months post-injection in patients with Grade II and III knee OA—the stages where joint damage is evident but not yet end-stage, making them ideal candidates for joint-preserving interventions.
A Strategic Collaboration Anchored in Innovation
The launch of Ciplostem represents more than a product debut—it symbolizes a strategic alignment between two Indian innovators committed to transforming healthcare through science. Cipla, renowned for its mission of “Caring for Life,” has long pioneered affordable access to essential medicines across therapeutic areas. Its expansion into advanced therapies like cell-based treatments signals a bold evolution toward next-generation, precision-driven solutions.
Stempeutics Research, founded with a vision to harness the power of regenerative medicine, has spent over a decade developing and clinically validating Ciplostem. The company operates India’s first DCGI-licensed GMP-compliant cell therapy manufacturing facility, ensuring rigorous quality control and scalability.
Dr. Jaideep Gogtay, Global Chief Medical Officer at Cipla, emphasized the therapy’s potential:
“At Cipla, our focus continues to remain on moving up the innovation curve and delivering next-generation therapies that improve overall patient outcomes. With Ciplostem, our aim is to bring a scientifically validated cell therapy option into everyday clinical practice, which significantly reduces pain, preserves joint function, and enhances mobility for up to 2 years after administration in knee OA.”
Echoing this sentiment, BN Manohar, MD & CEO of Stempeutics Research, highlighted the scientific rigor behind the therapy:
“At Stempeutics, our efforts have always been focused on developing therapies that address disease fundamentally. Ciplostem sets a new benchmark in regenerative medicine, reflecting years of dedicated research and robust Phase 3 evidence. We are pleased to partner with Cipla to extend the reach of this stem cell therapy in India, transforming scientific innovation into tangible patient impact.”
Implications for Indian Healthcare
The introduction of Ciplostem carries profound implications for India’s healthcare ecosystem. By offering a non-surgical, disease-modifying alternative, it has the potential to:
- Delay or prevent knee replacements, reducing surgical burden on hospitals,
- Lower long-term healthcare costs associated with chronic pain management and disability,
- Improve workforce productivity, as patients regain mobility and return to daily activities,
- Stimulate the domestic biotech sector, showcasing India’s capability to develop and commercialize complex advanced therapies.
Moreover, this launch aligns with national initiatives like “Make in India” and the National Biopharma Mission, which aim to position India as a global hub for biopharmaceutical innovation.
While regulatory approval is a critical milestone, widespread adoption will depend on clinician education, patient awareness, and integration into treatment guidelines. Cipla and Stempeutics are expected to roll out comprehensive training programs for orthopedic specialists, rheumatologists, and physiotherapists to ensure proper administration and patient selection.
Looking forward, the success of Ciplostem could pave the way for additional indications—such as hip osteoarthritis, tendon injuries, or even early-stage rheumatoid arthritis—further expanding the role of MSC-based therapies in India.
Source Link: https://www.cipla.com/
